6640--VISN 15- Clinical Laboratory Chemistry Immunochemistry Instrumentation

This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise because of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort. The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract based on this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice. The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) Company Name (b) Address (c) Point of Contact (d) Phone, Fax, and Email (e) UEI number (f) Cage Code (g) Tax ID Number (h) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? (i) Is your company considered small under the NAICS code identified under this SSN/RFI? (j) Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? (k) If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). (l) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (m) If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work. (n) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract number. (o) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? (p) Please provide general pricing of your products/solution for market research purposes (q) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract number. (r) Please provide general pricing of your products/solution for market research purposes (s) Must provide a capability statement that clearly addresses the organization s qualifications and ability to perform as a contractor for the work described below. Requirement: The VA Heartland Network 15 Contracting Office located at 3450 South 4th Street, Leavenworth, KS, 66048-5055 is seeking a potentially qualified contractor to provide Clinical Laboratory Chemistry Immunochemistry Instrumentation for the entire VISN 15 Health Care System. Please see the Statement of Work for more specific details and addresses. The North American Industry Classification System Code (NAICS Code) is 334516 (Analytical Laboratory Instrument Manufacturing), size standard 1,000 Employees. Based on this information, please indicate whether your company would be a Large or Small Business and have a socio-economic designation as a Small Business, VOSB or SDVOSB. Important Information: The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to this source sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to an acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Currently a total set-aside for Service-Disabled Veteran Owned Small Business firms is anticipated based on the Veterans Administration requirement with Public Law 109-461, Section 8127 Veterans Benefit Act. However, if response by Service-Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open may be used. Responses to this notice shall be submitted via email to Janie Juszczak at janie.juszczak@va.gov. Telephone responses will not be accepted. Responses must be received no later than Thursday, January 22, 2026, at 15:00 CST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this sources sought. Responses to these sources sought notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation. STATEMENT OF WORK INTENT: It is the intent of the Department of Veterans Affairs, VA Heartland Network (herein afterward referred as VISN #15) to establish a Cost-Per Reportable Result (CPRR)/ Cost per Test (CPT) for Automated Chemistry Immunochemistry Instrumentation and automation to support workflow. However, as requirements change, facilities within VISN 15 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the contract as new technology becomes available on the market. TBD PRICES AND TERMS: VISN 15 will provide an estimated volume by test as reflected in Attachment A, Tab B for each individual medical center and outpatient clinic laboratory. Pricing is based on the AVERAGE daily test volume per instrument/analyzer for each facility. The Government estimates the volumes per facility as listed in Attachment A, Tab A but does not guarantee volumes as listed; they are estimates ONLY. TERM OF AGREEMENT: TBD IDENTIFICATION: TBD ORDERING METHOD: The participating facilities may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions. DELIVERY TERMS: The delivery terms for all items ordered under the contract will be FOB Origen. Contractor will make shipping arrangements and prepay all shipping and handling costs. Contractor will promptly replace all Products lost or damaged in shipment. Contractor will be responsible for all disputes with the shipper and all insurance claims related to the shipment. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK SCOPE OF PROCUREMENT: The Vendor's instrumentation must be included on the National Veterans Health Administration (VHA) Oracle Health baseline list, specifically classified as "Deployed Available" under the 2025 CareAware Device List. This requirement pertains to instruments currently constructed for the device category "Oracle Health Laboratory Medical Device Integration," ensuring they are available and in use. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. Equipment must maintain or, preferably, reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory. If Contractor offers a family of analyzers, the technical evaluation panel will determine if instrumentation proposed meets needs of using facility. New equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment B. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards, and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts, should be forwarded to the designated individuals determined at contract award. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the regularly scheduled standing order/routine supplies delivery. The Contractor is required to provide differing automation levels for sites in VISN 15 based on TBD. The contractor must provide separate line items for CPRR billing and automation billing. DEFINITIONS: Cost per Patient Reportable Result (CPRR)- Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) 5 year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor s equipment and necessary for the generation of a patient reportable result. The per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required to produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI); (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors shall provide delivery, installation, and removal of equipment at no additional charge. Cost per Test (CPT)- Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 5 year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor s equipment and necessary for the generation and reporting of a test result; (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge. Business Associate Agreement (BAA)- Required Primary Processing Automation Line Pre-analytical processing equipment offered to each of the VA laboratories listed on TBD that will automate the pre-analytical specimen processing functions, as indicated in the general requirements section. Specimen Management System - A component of the Processing Automation Line that directs and manages the operation and components of the pre-analytical processing/automation system. Autoverification Workflow: Autoverification is a process whereby clinical laboratory results are released without manual human intervention. Autoverification uses predefined computer rules to govern release of results. These rules are set to enable analyzers and automation to connect through the VA Lab Instrument Manager (IM) device to properly file autoverified results in the VISTA LIS. Contractor Middleware Management System - Inventory Manager System: This component automates inventory receiving and tracking without the need for direct line-of-sight. Provides inventory status in real-time, minimizes patient care disruptions due to out-of-stock or expired inventory. Provides supply levels on demand from a single dashboard to better track consumables across a laboratory network. It tracks tabreagent usage with barcode technology. Business Performance Software- Throughput The speed that the equipment processes and/or operates reported in units per hour. Test Menu Refer to Attachment A, Tab B Wkld Est for desired test menu and estimated annual volumes by laboratory. GENERAL REQUIREMENTS Primary analyzer(s) Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer may serve as a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment. Operational and Technical features- The instrumentation offered shall be approved by the Food and Drug Administration (FDA) and be available on the Contractor s FSS Contract at the time of proposal submission and have the following: Primary Processing Automation Line Instrumentation. Processing Automation Line Instrumentation for Clinical Laboratory Chemistry/Immunochemistry Instrumentation may be comprised of the following modules: specimen management system, centrifuge, decapper, recapper/sealer, and refrigerated storage which are connected with an automated track or line according to the requirements of each respective laboratory, as listed in Attachment A, Tab C. Documentation provided will be used to determine if automation is feasible within each requesting laboratory. No award for automation will be finalized until all stakeholders at each participating site have signed off on proposed plans. Proposals should include a CAD diagram of proposed layout for each participating laboratory. Cost structure of the automation line should be separate from CPRR pricing. Provide Pricing for Automation on Attachment A, Tab C, Automation Pricing. The Processing Automation Line Instrumentation shall have the following: Sufficient capacity and throughput to meet the volume and service demands as defined in TBD. Specimen management system to manage and track sample progress and position. Specimen archival system that maps specimens to racks or refrigerated storage for easy retrieval once moved from the automation line. (Specimen Management System). Bulk input module to intake large drops of tubes automatically onto the line without requiring racking by hand. The ability, based on test requests, to sort specimens. (Line/Track System/ Specimen Management System) The ability to connect by a line or track system all primary and back-up testing analyzers offered in accordance with TBD. The ability to send processed specimens by means of a tracking system to the proper testing instrumentation to maximize efficiency and to maintain and standardize turnaround times of results. (Line/ Track System / Specimen Management System) Analyzers must have flexible STAT testing options to prioritize the most critical samples based on workflow. (Specimen Management System). System has random-access capability, with ability to optimize fastest time to completion. Equipment quoted should have the ability to meet a 60-minute turnaround time from sample arrival in laboratory to release of results at least 95% of the time. Routine turnaround time (excluding Community Based Outpatient Clinics) should be completed in less than 60 minutes (Lab Arrival to Result Time) 95% of the time. Contractor agrees to a business review at least once per year to ensure that quality metrics are met. Minimal operator intervention when introducing a STAT specimen or when changing a routine specimen to a STAT specimen. (Specimen Management System) The ability to detect processing errors and provide error notification. (Specimen Management System) The ability to separate the serum/plasma from the blood cells through the process of centrifugation. Vendor to provide a minimum of 2 temperature- controlled centrifuges with adjustable spin time and RPM settings, with the option to bypass the centrifuge without manual intervention. (Centrifuge). The ability to remove the collection caps from a variety of types and sizes of blood collection tubes. (Decapper) The ability to replace and/or reseal a variety of types and sizes of blood collection tubes. Decapping and resealing system in an enclosed environment. (Recapper/Resealer) Barcoding stations located at key points along the line or track system must have the following capabilities: A barcode reading accuracy rate of 99% or greater for any component that requires barcode reading. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha and numeric concurrently. The ability to manage inventory of reagents. (Inventory Management) Vendor must provide non-linear or linear configuration of conveyor system for transportation of specimens to analyzers for optimal space utilization in lab and minimal disruption of current workflow and space. Pre/post analytical processor must fit within currently allocated space. Current space is limited by support columns and access hallways in the laboratory and defined in the below table. Facilities Question #2- Automation Line Kansas City VAMC 63 ft long x 12 ft wide Leavenworth VAMC 18 FT L x 8 FT W East wall 22 FT L x 15 W North area Marion VAMC  15 L X 17 W St. Louis VAMC  17 wide x 55 long Topeka VAMC Has a U configuration 18 L x 8 W East wall 18 L x 7 W North wall 23 L x 14 W Middle area Columbia VAMC 65 ft long x 12 ft wide (my need updating) Vendor shall provide refrigerated sample storage with enough space to store approximately 7,000 samples for up to 7 days. Disposal times must be programmable allowing multiple settings, ie: hematology may be disposed after three days, chemistry after 7. Testing Instrumentation: The testing instrumentation must be approved by the Food and Drug Administration (FDA) and be available at the time of proposal submission and shall have the following: The capability of performing analysis on the tests listed in TBD. System must be able to connect to current automation system. Ability to manage testing workflow of hospital laboratory. Analytical configuration of chemistry and immunoassay platforms must provide for backup analyzer(s) with equivalent menus utilizing the same reagent formulation to ensure correlation with primary instrument and backup instrumentation. The system must contain random access technologies that improve workflow. The system must be scalable on site to accommodate anticipated increases in workload and to acquire improved technology. The system must fit in the space available listed below: Facilities Question #1- Basic Requirements/Analyzers Columbia VAMC  15 FT X15 FT Evansville HCC  5 FT X 15 FT Kansas City VAMC  25 FT long x 12 FT wide.
Leavenworth VAMC  18 FT L x 8 FT W East wall 22 L x 15 W North area Marion VAMC  15 L X 17 W Poplar Bluff VAMC 26 FT Long x 7 ft Wide Cape Girardeau HCC 10.5 ft long x 3 ft wide, also add 3 ft to get behind analyzer St. Louis VAMC  6 FT x 4 9 (6 instruments) Jefferson Barracks Division  11 FT x 5 FT Topeka VAMC  Has a U configuration 18 L x 8 W East wall 18 L x 7 W North wall 23 L x 14 W Middle area Wichita VAMC   127 x 49 does not include any peripherals such as printer/monitor/etc. There is only about 15-inch clearance space behind analyzers backing up to a wall; no additional space in front. Sufficient capacity and throughput to meet the volume and service demands as defined in TBD. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha and numeric concurrently that may be enabled concurrently. A barcode reading accuracy rate of 99% or greater. Integrated modules must only require one system control center (computer and screen) to simplify operations. Equipment must have the ability to monitor instrument performance Continuous monitoring of vital instrument functions with immediate operator notification of failure(s). A record(s) of the vital instrument function failure(s) must be maintained and stored electronically on-board the equipment. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. Capability to capture, store and print the following information: Instrument maintenance information. Patient demographic information. Specimen results. The ability to print patient reports in chartable medical record format for use during downtime operations. On board reagent inventory management system must have: Analyzers must be capable of monitoring reagent usage, maintaining and storing on board supplies/reagents for 24 hours of patient testing on the combined platform, and providing reagent inventory upon request, in real time. A system that provides reagent data to include but not limited to lot number, expiration date, and the number of remaining tests available for use on the analyzer(per analyte). Bar coding of reagents and the ability to track reagent containers throughout the testing process through the use of bar code technology. A barcode reading accuracy rate of 99% or greater. Minimal operator intervention when introducing a STAT specimen or when changing a routine specimen to a STAT specimen. The introduction of a STAT specimen must not compromise existing programmed testing. Instruments must be available for full front loading of samples, reagents, consumables and bulk solutions with minimal disruption of workflow if the automation line is down for any reason and STATs must take priority over routine testing. Primary tube sampling from evacuated collection tubes of various sizes and from various manufacturers. Capable of handling all routine sample collection tubes plus other various sized sample containers, e.g. sample cups (0.5, 1.0, and 2.0 ml), carrier tubes and tube inserts. The ability to continuously load patient specimens. The ability to detect short samples. Instrument must have liquid level sensing, clot, foam and bubble detection with alert notification. Instrument must perform specimen integrity evaluation on all samples as needed at no additional cost. This is, the ability to detect and flag for hemolysis, lipemia and icterus. Hemolysis, icterus and lipemia interference threshold for analytes shall be provided/validated by the manufacturer. The Government reserves the right to review all proposals based on individual merit and make a medical based decision on the system(s) offering least interference and provides best overall value to the Government. Analyzers must have minimal carryover and not require the use of disposable pipette tips or aliquots or specific aspiration order of assays. The ability to perform testing with limited interference from human anti-mouse or heterophilic antibodies, high dose hook effects, and other interferences assuring the highest result integrity. Instruments must offer extended linearities to reduce the number of dilutions and increase first pass resulting. The capability to auto dilute a test when defined limits are exceeded. For sites using autoverification, the ability must exist to accept a download of an order from the sites existing Data Innovations middleware. (Contractor shall indicate on TBD Info each analyte that can be set to auto dilute on each instrument model offered.) The capability to program a test to perform a repeat analysis, reflex, and auto-rerun. The repeat test result must be able to cross the interface and overlay the initial result. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. For those sites requiring back up analyzers, it would be desirable for the backup analyzer to be a mirror image or have the same reagent requirement as the primary analyzer. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. Equipment relocation and possible reinstallation should the equipment need to be moved due to construction or laboratory redesign at no additional cost for one (1) relocation within each site. Ability to maintain use of the equipment if the Automation Line were to be in an off-line status for service or maintenance. Open channel chemistry availability for adaptation of commercially available reagents not produced by vendor. The vendor must have limited factory recalls of reagents and instrumentation. Please include all factory recalls for the last 18 months. Surveillance package within a Business Performance platform that provides automated reports to regulatory bodies for infectious disease management programs such as Covid-19, monitoring diagnostic rates by postal code, testing sites, ordering provider, gender, or age. Analyzer utilizes windows operating software or other VA approved operating system. Vendor will complete and return the following attachments: 6550 Pre-Procurement Assessment MDS2 Manufacturer Disclosure Statement for Medical Device Security Instrument Quality Control System On-board QC data management system with minimum storage capacity of 600 QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data to BIORAD, Technopath or other Quality Control program or disk storage. Shall provide ability to peer review external comparison data for quality control materials and have inter-laboratory peer comparisons forwarded monthly. Average peer group size shall be sufficient to enable adequate monitoring and comparison of results. A peer group shall be at least 10 peers for an established lot number of quality control. Ability to on-line document QC out of range. Ability to read barcoded QC. Ability to store quality control values for second lot number during crossover studies. Ability to retain quality control data from second lot number when put into use. Ability to edit or correct errors of QC files manually. The quality control material shall be included in the contract for all tests in use (credit towards purchase). Contractor shall provide lot number coordination to ship the same lot (minimum suggest outdate for controls lots shall be more than one year). Capability to detect and alert operator of out of range quality control results via flagged results on QC printout and visual alerts on display monitor. Patient testing is disabled if QC failure occurs. The technology must allow electronic transmission of quality control data to BIORAD, Technopath or other Quality Control program through the VA owned Data Innovations Middleware. For general chemistry tests, when more than one lot of a given reagent has a valid calibration on the analyzer and quality control material is programmed to run as a control (in the control mode). The ability to run old lots of QC concurrently with new lots for parallel testing. Quality control material will automatically be run on all lots of those reagents when the respective test is requested. Quality control results will be easily distinguishable i.e., identified by reagent lot number or similar mechanism, on instrument printout or display monitor. Operator may select to run a test on only a specified lot of reagent even though more than one lot has a valid calibration. Quality control frequency not to exceed once/24 hours/instrument platform. Minimum quality control frequency for NA/K/CL not to exceed once/8 hours/instrument platform. Reagents Convenient Reagent and Standard Use. On board reagent stability sufficient to accommodate both high and low volume use. The ability to detect and alert operator of low liquid levels and the potential of depletion. The ability to unload/remove empty reagent containers from the equipment during operation without interrupting testing in progress. The ability to calibrate and support more than one (1) reagent lot of the same reagent on the equipment at the same time. The capability to calibrate assays during test run without aborting the run. Extended Calibration life for most analytes with little or no daily/weekly calibration. Automatic calibration of electrolytes. Analyzer has the ability to notify user when calibration is within one hour of expiration. Liquid calibrators for most or all tests with minimal calibrator preparation. List any calibrators that require preparation and the required process. Long calibration stability. The capability of incorporating other manufacturer s reagents. The capabilities to store, print, and retrieve calibration data. Each clinical chemistry module must have a minimum 70 reagent slots and each immunoassay analyzer must have a minimum of 47 reagent slots to allow for maximum load up of reagents to increase walkaway time and reduce technologist intervention. Reagents with little or no reagent preparation for most or all tests. Instrument shall have capability to flag new reagent packs prior to quality control use. Enzyme verifiers available to periodically check performance of enzyme tests that lack standards. IDMS traceable Creatinine reagent. Minimal requirements for sample pre-treatment. Minimal requirements for reagent/calibrator preparation. Reagents have prolonged shelf life and stability once opened and on board the analyzer. Various reagent sizes to allow economical usage by both small and large laboratories in VISN 15. Offeror shall characterize each method and provide exact vendor guaranteed minimum linearity/AMR, CRR limits in TBD. Contractor shall include linearity material for AMR verification. As new methods are released for the instrument, the updates are automatically enabled promptly and at no cost to user. Offer shall provide AMR Calibrator Values and Calibrator frequency in TBD Offer shall provide Percent (%) CV on assays in TBD. Interface Requirements The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see TBD). The Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in TBD. If a site already has a universal interface system, the Contractor is responsible for everything leading up to the connection to the software system, including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system. The Specimen Management system must be computer interface compatible with the current VA laboratory information system and existing universal interface. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. Auto-verification Support Contractor shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity through existing Data Innovations Middleware solutions. This collaboration may be accomplished by direct support by the contractor, by a subcontract to a mutually agreed upon secondary vendor or a combination of both. All rules necessary to support auto-verification will be written and tested prior to go live date for the new analyzer configurations. Support will be provided to assist with any issues that are found during the go live process for auto-verification and for at least one-month post go live. Analyzers should allow for auto-verification to be accomplished at each VA facility through existing VA owned Data Innovations Middleware solutions. Required Services: Autoverification Workflow Build and Deployment: Contractor must provide all necessary servers for a live environment, test environment and hot back up. Perform assessments of the autoverification workflow to gather and understand the rule logic needs. Design and implement autoverification rule set to enable analyzers and automation to connect through the VA Lab IM to properly file autoverified results in the VISTA LIS. DI Rules can include but are not limited to the following Rule types: QC Evaluation Rerun Comparison Error Flags Result Formatting Serum Indicies Reference Ranges Critical Results Delta Check Calculations Specimen Integrity Reflex Tests LIS Formatting Validate or Hold for Review Work with the Laboratory LIM s, interface the VISTA/ORACLE Cerner LIS with vendor provided Middleware for automation tracks. Work with the Laboratory LIM s to interface the VISTA/ORACLE Cerner LIS with vendor provided chemistry instruments. Provide up to ten (10) hands on tutorials on IM Rule set usage, maintenance, and stewardship. Provide up to ten (10) hands on tutorials on creation and execution of test cases within the IM Rules engine. During testing and validation phase, provide remote or onsite guidance on validation techniques and assist with troubleshooting and/or rule modification, as needed, in preparation for Go-Live Provide guidance and assistance with design and configuration of up to twenty (20) unique Specimen Management workspaces to manage results that failed the Autoverification process. Provide up to thirty days of dedicated Autoverification go-live assistance to be used at VISN 15 s discretion. Post Go-Live Autoverification Maintenance Provide support and guidance during routine modifications of final Autoverification build, such as: Adding or removing tests to instrument menu and incorporation into Rules logic Modifying Rules logic cut-off values based on evolving lab SOP s. Tweak existing Specimen Management Workspaces, Moving Averages/Moving Medians, CAP eLab Solutions Connect, Notifier or Laboratory Intelligence configurations. Changes to User Security Group Roles Assistance, as needed, during annual Rule re-validation associated with regulatory requirements utilizing original project test script and validation plan. Two annual remote health checks per site to review workflow and provide enhancement or optimization ideas, as necessary. The Contractor shall provide upgrades to the middleware software. Contractor Middleware Management System - Automation Line Sufficient memory to store data requirements for operation of Primary Processing Automation Line. Supports workflow management that supports all integrated (linked) testing instrumentation and Primary Processing Automation Line. Contractor shall assist customer with optimizing operation and utilization of the data management system to fully integrate desired automation enhancing productivity and management of workflow. Middleware will be used as a pass through for analyzer Autoverification Rules. Vendor must supply a mobile (mounted on wheels) command center monitor at least 42 screen which will allow the technologists to monitor the instruments (split screen) and connections. Ability for instruments to maintain interface if automation system goes offline for repairs or maintenance. Equipment Preventative Maintenance/Repair Service The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation, primary processing automation line instrumentation and any incremental support/ancillary equipment, e.g. water system, printers, etc. offered according to the following terms: Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 1 hour(s). Equipment repair service shall be provided during core business hours. See TBD defining core business hours of each facility included in this solicitation. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. Perform QC and verify it passes before leaving or closing the service call. Parts replacement verification steps to verify new parts performance. This needs to be listed in the service report that is given to the site. Contractor must have the ability to remotely monitor all instruments on the line at one time in one place using via a Software to minimize instrument downtime and increase staff efficiency. This includes immediate notification of operating state, alerts, reagents and supplies status, QC and calibration inventory and status, and maintenance status. Analyzers must have minimal daily, weekly, and monthly maintenance downtime. Please provide total maintenance times, including washes and wait times, for daily, weekly and monthly maintenance. Please include any hands-on, automated non-maintenance activities. Equipment repair response time shall be no more than 24 hours. Please provide location of service personnel in relationship to the VISN 15 Medical Centers and Evansville Indiana CBOC. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: date and time notified date and time of arrival serial number, type, and model number of equipment time spent for repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. Each notification for an emergency repair service call shall be treated as a separate and new service call. Vendor will supply any needles/probes or supplies necessary to keep the equipment operational. If upgrades or changes in technology render a piece of equipment no longer necessary, contractor shall remove said piece at contractor s expense. Please provide an independent quote for each site to potentially have their own service contract for both a general service contract agreement as well as a quote for an upgraded service agreement and what each entails. Hardware Features- The instrumentation shall have the following: All monitors/screens will clearly display information in all light conditions. A printer(s) that has the capability of printing a patient report with patient demographic information that includes minimally the patient s name and accession or unique identifier number (UID). An uninterruptible power supply (UPS) with line conditioner for each instrument provided. (This includes UPS units for sites with automation lines, specimen management systems, data management systems, refrigerated storage, etc.,) Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records. Method Performance/Validation Requirements Please provide the implementation and post-implementation plan for training, IT support and customer optimization Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) and The Joint Commission (TJC) standards and Federal regulations. All studies performed will be appropriate for the test menu of the respective laboratory to include serum, plasma, urine, and body fluids, as applicable. These validation requirements are applicable to all new testing analyzers. Correlation studies for each analyte. Vendor to provide all reagents, calibrators, and controls needed along with technical assistance to perform correlation studies from a single lot at no additional cost for new test methods or changes in test menus. (i.e., vendor is to provide all manpower and reagents/supplies to do correlation studies). A minimum 20 samples spanning the reportable range, shall be run comparing the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI. Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum. Precision study using normal and abnormal control material. This shall include, at a minimum, within run precision study of 10 normal and 10 abnormal controls. Intra-VISN facility variations should be kept at an absolute minimum. Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate, and false negative rate are applied. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances. Carryover Studies. Successful carryover studies shall be completed by the contractor on all analyzers during installation. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge. Reference Range- A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used: A verification of the manufacturer s suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used to verify the manufacturer s range. Any apparent outliers should be discarded, and new specimens obtained to provide a statistically valid verification. If the suggested manufacturer s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method. If a laboratory is currently using the proposed instrument/reagent system, the in-use reference range can be transferred to the new system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items mu/t be performed. Data will be aggregated from each site to determine a VISN reference range. Reports- Support Features Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. This applies to all equipment as well as additional or replacement equipment placed under the terms and conditions of this contract. The Contractor shall perform/assist, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all of the statistical analysis as stated in the Method Performance/Validation section above and provide a hard copy of data in an organized, clearly comprehensible format. Commercial offerings - The Contractor shall provide operator and service manuals along with CLSI compliant procedures must be furnished for each instrument model supplied, unless provided electronically on board the instrument. Vendor to write Standard Operating Procedures for each assay in the laboratory template, to ensure that procedures are totally available prior to implementation. Documentation: A current editable, electronic (Microsoft Word) copy of the instrument operating guide(s) and procedures shall be provided to each site. The document(s) shall be formatted in accordance with current, approved CLSI guidelines. Electronic (CD Format). At a minimum, electronic copies of Safety Data Sheets (SDS) shall also be provided. Updates to all procedure manuals in Microsoft Word format and SDS sheets in electronic format shall be provided when package inserts are modified. Training. The Contractor shall provide an instrument training program. In addition to the training above the following shall be provided: Basic operator training shall be provided by Contractor on-site for all operators on all shifts, as applicable. Advanced training shall be provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization for 2 key operators if middleware is required for automation. If training program involves off-site travel, contractor shall cover the cost of airfare, room, and board for each participant. Upgrades - The Contractor shall provide upgrades to both the equipment hardware, and software in order to maintain the integrity of the system and the state-of the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. Advanced notification and approval of the sites is necessary prior to doing software upgrades. Use of thumb drives at certain facilities require scanning prior to use by onsite OIT/BioMed. This does not refer to replacing the original piece of equipment provided under the contract; however, it does refer to significant changes in the hardware operational capability. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the contract , as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary). Vendor must provide three-tiered utility carts for the computer and printer associated with the analyzers. Vendor must provide an Integrated high laboratory grade water system with provision for uninterrupted water supply during maintenance/change over. Service contract covering the term of the agreement must be included at no additional cost to the facilities. The water system company should be situated in close proximity to each individual facility rather than being organized on a regional basis. Meet the space limitations listed below (water system to be in separate location). Facilities Water Room Space Requirements Columbia VAMC  15 FT X 7 FT Rolla Super CBOC 5 FT x 3 FT Evansville HCC Remote location is an odd shape space but roughly 10 x12 , or adjacent to the analyzer at 3 x3 . Kansas City VAMC New water system in the works for the future; current space is 8 FT x 8 FT Leavenworth VAMC  5 FT x 3 FT Marion VAMC  Water System currently is in a room above the laboratory. There is the possibility of having one in the lab instead. It would need to feed the chemistry instruments, hematology instruments, and spigots in the lab. Space needed if moved to lab would depend on size of instruments, if it remains above the lab there is no limitation. Poplar Bluff VAMC  12 FT X 6 FT Cape Girardeau HCC 4 ft long x 7 ft tall x 16 inches wide (current unit hangs on wall) St. Louis VAMC   5.5 FT x 5.5 FT
Jefferson Barracks Division  Must be bench top space available 4 FT x 2.5 FT Topeka VAMC   5 FT x 4 FT
Wichita VAMC Water system is situated centrally between the two chemistry analyzers with feeds to both. There is also a connection to the house DI water whereby supply can be diverted to house system in the event of the water system failure. Foot print of current system is approximately 34 x 22 without connective paraphernalia. Vendor must include consumable polishers, filters, preventative maintenance and repair, etc.), printers and universal interface equipment, UPS Batteries, etc. for the life of the contract. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc. Characterization of waste The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 Protection of the Environment Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated. The determination and description shall address the following: Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) Waste ignitability (Reference 40 CFR §261.21) Waste corrosivity (Reference 40 CFR §261.22) Waste reactivity (Reference 40 CFR §261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33) Solid Waste (Reference 40 CFR §261.2) Exclusions (Reference 40 CFR §261.4) Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response: Barium (Total) Cadmium (Total) Chromium (Total) Copper (Total) Cyanide (Total) Lead (Total) Mercury (Total) Nickel (Total) Silver (Total) Zinc (Total) Arsenic (Total) Selenium (Total) Tin (Total) pH Flash point (to higher than 200°F) BOD; biochemical oxygen demand The documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after the award of the contract. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 120-day timeframe if the extension is through no fault of the Contractor and is a result of delays due to the Government. Upon award of a contract, the transition period for the awarded contract to have all equipment and peripherals installed and operational shall be from date of award through 120 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor s submitted plan shall not exceed 120 days for the transition of all services under the awarded contract including installation and training of personnel, transition of all testing materials, reagents, and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract. . Standard and Quality of Performance: Will be in solicitation